A Double-blind, Oral, Multiple-dose, Parallel, Randomized Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients with Acute Mania Episodes with or Without Mixed Features

Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm. Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is safe and active.

Start Date19 Mar 2024

Sponsor / Collaborator

Jina Pharmaceuticals, Inc.

[+1]

NCT06075953 / RecruitingPhase 2

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease.
Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

Start Date14 Feb 2024

Sponsor / Collaborator

Quantumleap Healthcare Collaborative

NCT05607004 / RecruitingPhase 2

A Randomized Phase 2 Non-inferiority Trial of (Z)-Endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment in Premenopausal Women With ER+/HER2- Breast Cancer

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal (still having periods) women with ER+/HER2- breast cancer. (Z)-endoxifen is a selective estrogen receptor modulator or "SERM." SERMs work to treat cancer by blocking the body's natural estrogen from binding to cancer cells. This study includes a pharmacokinetic part (PK, how the drug works in your body) and a treatment part. The primary purpose of the study is to see how (Z)-endoxifen works on tumor cell growth by monitoring a cancer marker called Ki-67. Ki-67 will be measured by biopsy of the breast after about 4 weeks of treatment. If your cancer is responding to treatment based on the Ki-67 results, you may continue treatment up to 24 weeks or until surgery.
The PK part of the study will be enrolled first, enrolling about 18 study participants who will all receive oral once daily (Z)-endoxifen treatment. 12 of these participants will be randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or (Z)-endoxifen + goserelin (a medication given to block the ovaries from making estrogen and is also called ovarian suppression). This part of the study will help select the dose of (Z)-endoxifen to use in the treatment part by measuring the levels of (Z)-endoxifen in the blood stream and determine how long it takes for the body to remove it.
About 160 study participants will be enrolled in the treatment part. The treatment part will help to determine how oral once daily (Z)-endoxifen, when taken by itself, compares to oral once daily exemestane (a medication that decreases the amount of estrogen in the body, also known as an aromatase inhibitor) and monthly injections of goserelin. Exemestane and goserelin taken together is a standard treatment regimen for premenopausal patients with ER+/HER2- breast cancer. Study participants are randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or standard treatment.
Study participation is up to 24 weeks of treatment followed by surgery.

Start Date14 Feb 2023

Sponsor / Collaborator

Atossa Therapeutics, Inc.

[+1]

100 Clinical Results associated with Endoxifen

100 Translational Medicine associated with Endoxifen

100 Patents (Medical) associated with Endoxifen

538

Literatures (Medical) associated with Endoxifen

21 Sep 2024·Indian Journal of Psychological Medicine

The Antimanic Effect of Endoxifen in Patients with Bipolar Disorder with Renal Comorbidities: Case Series.

Article

Author: Kuraria, Astut ; Vishwanath, Rashmi ; Nagaraj, Anil Kumar M ; Kamath, Avinash ; Soman, Savitha

The conventional and standard pharmacological approaches in the management of bipolar disorders include mood stabilizers and second-generation antipsychotics. However, renal problems owing to the gold standard mood stabilizer, lithium, is three times that of the general population. As bipolar I disorder (BPD I) is associated with overactive protein kinase C (PKC) intracellular signaling, a novel approach in the management of acute mania/mixed affective states of bipolar disorder includes the use of PKC inhibitors, such as Tamoxifen and its derivative metabolite molecule, Endoxifen. Our objective is to report two cases of bipolar disorder that presented in acute manic episodes, with preexisting renal disease, and safe use of Endoxifen as an adjunct/monotherapy for rapid control of symptoms. According to our study, Endoxifen can be used as an anti-manic agent, either as monotherapy or as an adjunct, in patients with renal disease. It can also be used as an effective cover therapy for bipolar disorder patients requiring steroids for the treatment of renal pathology, though long-term studies are needed to assess the long-term safety and efficacy.

01 Sep 2024·Clinical pharmacology and therapeutics

Nonlinear Mixed‐Effects Model of Z‐Endoxifen Concentrations in Tamoxifen‐Treated Patients from the CEPAM Cohort

Article

Author: Guchelaar, Henk-Jan ; Swen, Jesse J ; Mikus, Gerd ; Mathijssen, Ron H J ; Hertz, Daniel L ; Michelet, Robin ; Mc Laughlin, Anna M ; Helland, Thomas ; van Schaik, Ron H N ; Kloft, Charlotte ; Dalenc, Florence ; Thomas, Fabienne ; Søiland, Håvard ; White-Koning, Melanie ; Klima, Fenja ; Neven, Patrick ; Mellgren, Gunnar ; Schwab, Matthias ; Brauch, Hiltrud ; Mürdter, Thomas ; Koolen, Stijn L W ; Schroth, Werner

Tamoxifen is widely used in patients with hormone receptor‐positive breast cancer. The polymorphic enzyme CYP2D6 is primarily responsible for metabolic activation of tamoxifen, resulting in substantial interindividual variability of plasma concentrations of its most important metabolite, Z‐endoxifen. The Z‐endoxifen concentration thresholds below which tamoxifen treatment is less efficacious have been proposed but not validated, and prospective trials of individualized tamoxifen treatment to achieve Z‐endoxifen concentration thresholds are considered infeasible. Therefore, we aim to validate the association between Z‐endoxifen concentration and tamoxifen treatment outcomes, and identify a Z‐endoxifen concentration threshold of tamoxifen efficacy, using pharmacometric modeling and simulation. As a first step, the CYP2D6 Endoxifen Percentage Activity Model (CEPAM) cohort was created by pooling data from 28 clinical studies (> 7,000 patients) with measured endoxifen plasma concentrations. After cleaning, data from 6,083 patients were used to develop a nonlinear mixed‐effect (NLME) model for tamoxifen and Z‐endoxifen pharmacokinetics that includes a conversion factor to allow inclusion of studies that measured total endoxifen but not Z‐endoxifen. The final parent‐metabolite NLME model confirmed the primary role of CYP2D6, and contributions from body weight, CYP2C9 phenotype, and co‐medication with CYP2D6 inhibitors, on Z‐endoxifen pharmacokinetics. Future work will use the model to simulate Z‐endoxifen concentrations in patients receiving single agent tamoxifen treatment within large prospective clinical trials with long‐term survival to identify the Z‐endoxifen concentration threshold below which tamoxifen is less efficacious. Identification of this concentration threshold would allow personalized tamoxifen treatment to improve outcomes in patients with hormone receptor‐positive breast cancer.

01 Jul 2024·Clinical pharmacology and therapeutics

A Genome‐Wide Association Study of Endoxifen Serum Concentrations and Adjuvant Tamoxifen Efficacy in Early‐Stage Breast Cancer Patients

Article

Author: Dezentjé, Vincent Olaf ; Sanchez‐Spitman, Anabel Beatriz ; Böhringer, Stefan ; Guchelaar, Henk‐Jan ; Gelderblom, Hans ; Swen, Jesse Joachim

Tamoxifen is part of the standard of care of endocrine therapy for adjuvant treatment of breast cancer. However, survival outcomes with tamoxifen are highly variable. The concentration of endoxifen, the 30–100 times more potent metabolite of tamoxifen and bioactivated by the CYP2D6 enzyme, has been described as the most relevant metabolite of tamoxifen metabolism. A genome‐wide association study (GWAS) was performed with the objective to identify genetic polymorphisms associated with endoxifen serum concentration levels and clinical outcome in early‐stage breast cancer patients receiving tamoxifen. A GWAS was conducted in 608 women of the CYPTAM study (NTR1509/PMID: 30120701). Germline DNA and clinical and survival characteristics were readily available. Genotyping was performed on Infinium Global Screening Array (686,082 markers) and single nucleotide polymorphism (SNP) imputation by using 1000 Genomes. Relapse‐free survival during tamoxifen (RFSt) was defined the primary clinical outcome. Endoxifen serum concentration was analyzed as a continuous variable. Several genetic variants reached genome‐wide significance (P value: ≤5 × 10−8). Endoxifen concentrations analysis identified 430 variants, located in TCF20 and WBP2NL genes (chromosome 22), which are in strong linkage disequilibrium with CYP2D6 variants. In the RFSt analysis, several SNP were identified (LPP gene: rs77693286, HR 18.3, 95% CI: 15.2–21.1; rs6790761, OR 18.2, 95% CI: 15.5–21.1). Endoxifen concentrations have a strong association with the chromosome 22, which contains the CYP2D6 gene.

News (Medical) associated with Endoxifen

30 Apr 2024

·www.prnewswire.com

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

USA News Group Commentary VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE). Following a Fast Track Designation by the FDA in late 2022 for Oncolytics Biotech Inc.'s (NASDAQ: ONCY) (TSX: ONC) drug candidate, pelareorep, for pancreatic cancer treatment, the company is now gaining traction towards another pivotal FDA engagement, this time focusing on breast cancer. Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients. "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics. "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and registration." Dr. Coffey has shared that Oncolytics' continuous interactions with clinical collaborators and partners have been instrumental in crafting a detailed and persuasive briefing document. The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer. This meeting is crucial for advancing this promising therapy toward patient use. With expected survival data from its BRACELET-1 study and constructive dialogues with the FDA, Oncolytics is optimistic that 2024 will be a landmark year for the company and its stakeholders. "The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients." Also seeking the FDA's attention, Israel-based IceCure Medical Ltd (NASDAQ: ICCM) recently reported its final ICE3 breast cancer cryoablation trial results with 100% patient and physician satisfaction and 96.3% recurrence-free rate for its ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. With this new data in hand, IceCure has submitted final data to the FDA, requesting marketing authorization for ProSense® for the indication of treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense® has already received FDA Breakthrough Designation and is cleared for use in the US for several other indications, including treating benign tumors of the breast, and tumors in the kidney and liver. "We believe ICE3 is a ground-breaking study and are excited to report that the efficacy data of our minimally invasive ProSense® cryoablation procedure show similar outcomes in recurrence compared to more invasive breast surgery, the current standard of care for early-stage breast cancer," said Eyal Shamir, CEO of IceCure. "Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA's response. Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval." A new clinical trial was announced by Atossa Therapeutics, Inc. (NASDAQ: ATOS) to evaluate the company's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer. Set to enroll approximately 20 newly diagnosed women, the new study arm will have participants receiving 40mg (Z)-endoxifen once daily in combination with 150mg abemaciclib twice daily for a total of 24 weeks prior to surgery. "Endocrine therapy in combination with CDK 4/6 inhibition is a widely used treatment for patients with advanced-stage ER+ breast cancer and as an adjuvant therapy for node positive, hormone positive early-stage disease, found at the time of surgical resection," said Dr. Laura Esserman, director of the University of California San Francisco Breast Care Center and founder of Quantum Leap Healthcare Collaborative. "Women with high clinical stage but less proliferative tumors (molecularly low risk or those with late recurrence risk) are challenging to treat. Late recurrence is high regardless of either endocrine or chemotherapy. Thus, we are looking for new combined treatments, which can be used in the pre-surgery (neoadjuvant) setting. We look forward to learning more about the potential of (Z)-endoxifen in combination with abemaciclib in the neoadjuvant setting in the I-SPY TRIAL." Vepdegestrant (ARV-471) is another treatment that recently received FDA Fast Track Designation, which is a novel oral PROteolysis Targeting Chimera (PROTAC®) ER degrader that is being jointly developed by Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE). The ongoing Phase 3 VERITAC-2 clinical trial is evaluating vepdegestrant or fulvestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer who have been previously treated with an endocrine-based therapy. "The receipt of Fast Track designation reinforces the potential of vepdegestrant to provide an important new therapeutic option for people with ER+/HER2- breast cancer whose disease has progressed," said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. "We are proud to continue our legacy of developing innovative treatment options for people impacted by metastatic breast cancer and look forward to working with the FDA as we advance our development program for vepdegestrant." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Fast TrackPhase 2Clinical ResultBreakthrough Therapy

26 Jan 2024

·www.pharmaceutical-technology.com

Atossa Therapeutics progresses Phase II preventative breast cancer therapy

Atossa Therapeutics’ CEO discussed updates for its breast cancer program. Credit: NDAB Creativity via Shutterstock Atossa Therapeutics estimates a Q3 readout of a Phase II trial that studies the company’s lead asset z-endoxifen, says CEO Dr. Steven Quay, in an interview with Pharmaceutical Technology . In December, the US-based biotech announced that it had completed enrollment for its Karisma endoxifen Phase II trial (NCT05068388), reaching 80% of its initial goal. Atossa is conducting the study at the South General Hospital in Stockholm, recruiting 240 pre-menopausal women with measurable MBD. Quay said that the company estimates a Phase II data readout for the trial in Q3 2024. The Karisma study is investigatings Z-endoxifen as a preventative treatment for breast cancer. Quay mentions that the US Food and Drug Administration (FDA) typically does not approve preventative therapies for cancer as many patients pass away during the trial. Furthermore, he highlights the uncertainty surrounding the ideal trial length for preventative studies and choosing the necessary endpoints. The company plans to discuss Phase III plans with the FDA to devise an appropriate trial design. Atossa is also investigating the drug in the I-Spy 2 trial (NCT01042379) and the EVANGELINE trial (NCT05607004) for the treatment of ER+ invasive breast cancer in pre-and postmenopausal women and grade 1 or 2 ER+/HER2 breast cancer in premenopausal women respectively. Z-endoxifen acts by binding to oestrogen receptors, causing a blockage of the oestrogen-dependent gene. The therapy has a patented oral enteric capsule formulation that stabilises it upon oral administration. In 2024, the company plans to present data from its ongoing trials at multiple conferences, says Quay. This includes the American Association for Cancer Research (AACR) annual meeting in April, and the American Society of Clinical Oncology (ASCO) annual meeting in June, says Quay. In a 9 January letter to investors, Quay declared that the company had “a strong balance sheet with no debt and cash, cash equivalents and restricted cash of $94 million as of September 30, 2023.” The company achieved this through the June 2023 launch of a share repurchase program, which allowed them to raise $1.475 million in 2023, amongst other things. The company has extended this share repurchase program through to 31 December 2024. The program permits the purchase of up to $10 million of Atossa’s common stock, including purchases made in 2023. Quay says the company is also open to partnerships to potentially test its drug in a combination therapy setting . He says that once Phase II data has released, the company may leverage it to begin partnership discussions.

Phase 2ASCO

18 Dec 2023

·www.prnewswire.com

Physician-Scientist Steven Quay Speaks to Victor Davis Hanson about lockdowns, mRNA vaccines, and the origins of the COVID virus

SEATTLE and PALO ALTO, Calif., Dec. 18, 2023 /PRNewswire/ -- Physician-Scientist Dr. Steven Quay, MD, PhD sat down again for a lengthy discussion on the evidence for the cost-benefit of the lockdowns, the real nature of mRNA vaccines, and the controversies over the origins of SARS-CoV-2 in the Wuhan China lab. The one-hour podcast can be found here. "It is always a pleasure to speak to Victor in this conversational format on important topics of public health interest," stated Dr. Steven Quay, MD, PhD. "In this podcast we were able to explore three of the most important topics to come out of the COVID-19 pandemic: With the benefit of hindsight, what is the cost-benefit analysis of the draconian public health measures taken in 2020, the lockdowns, business closures, and the like? With the benefit of millions of doses and over two years of long-term safety and efficacy data, what have we learned about the mRNA vaccine technology? And given the overwhelming evidence that SARS-CoV-2 was the product of gain-of-function experimentation on a bat coronavirus backbone, where do we go from here in regulating this dangerous research?" "As we approach the three-year anniversary of the emergence of SARS-CoV-2 from China and the beginning of the worldwide pandemic that, in many ways, fundamentally changed the relationship of government and the consent of the governed, it is critical that we examine the things that were done right and the mistakes that were made," said Victor Hanson. "The prospect of a future worldwide epidemic from a laboratory experiment gone wrong that could exceed the impact of the Black Plague of the Middle Ages requires the attention of all concerned citizens." ABOUT VICTOR DAVIS HANSON Victor Davis Hanson is the Martin and Illie Anderson Senior Fellow at the Hoover Institution; his focus is classics and military history. Hanson was a National Endowment for the Humanities fellow at the Center for Advanced Studies in the Behavioral Sciences, Stanford, California (1992–93), a visiting professor of classics at Stanford University (1991–92), the annual Wayne and Marcia Buske Distinguished Visiting Fellow in History at Hillsdale College (2004–), the Visiting Shifron Professor of Military History at the US Naval Academy (2002–3),and the William Simon Visiting Professor of Public Policy at Pepperdine University (2010). In 1991 he was awarded an American Philological Association Excellence in Teaching Award. He received the Eric Breindel Award for Excellence in Opinion Journalism (2002), presented the Manhattan's Institute's Wriston Lecture (2004), and was awarded the National Humanities Medal (2007) and the Bradley Prize (2008). Hanson is the author of hundreds of articles, book reviews, and newspaper editorials on Greek, agrarian, and military history, and essays on contemporary culture. He has written or edited twenty-four books, the latest of which is The Case for Trump (Basic Books, 2019). His other books include The Second World Wars (Basic Books, 2017); The Savior Generals: How Five Great Commanders Saved Wars That Were Lost - from Ancient Greece to Iraq (Bloomsbury 2013); The End of Sparta (Bloomsbury, 2011); The Father of Us All: War and History, Ancient and Modern (Bloomsbury, 2010); Makers of Ancient Strategy: From the Persian Wars to the Fall of Rome (ed.) (Princeton, 2010); The Other Greeks (California, 1998); The Soul of Battle (Free Press, 1999); Carnage and Culture (Doubleday, 2001); Ripples of Battle (Doubleday, 2003); A War Like No Other (Random House, 2005); The Western Way of War (Alfred Knopf, 1989; 2nd paperback ed., University of California Press, 2000); The Wars of the Ancient Greeks (Cassell, 1999; paperback ed., 2001); and Mexifornia: A State of Becoming (Encounter, 2003), as well as two books on family farming, Fields without Dreams (Free Press, 1995) and The Land Was Everything (Free Press, 1998). Currently, he is a syndicated columnist for Tribune Media Services and a weekly columnist for the National Review Online. ABOUT STEVEN QUAY, MD PHD Dr. Steven Quay has over 390 published contributions to medicine and has been cited over 11,700 times, placing him in the top 1% of scientists worldwide. He holds 236 US patents and patent applications. He has invented seven FDA-approved pharmaceuticals which have helped over 80 million people. He is the author of the best-selling book on surviving the pandemic, Stay Safe: A Physician's Guide to Survive Coronavirus. He is the CEO of Atossa Therapeutics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology, including his patented Z-endoxifen for breast cancer and other conditions. He received his M.D. and Ph.D. from The University of Michigan, was a postdoctoral fellow in the Chemistry Department at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-MGH Hospital, and spent almost a decade on the faculty of Stanford University School of Medicine. A TEDx talk he delivered on breast cancer prevention has been viewed over 228,000 times. He has testified twice in the US Congress on the origin of SARS-CoV-2 and the risks of gain-of-function virology research. For more information, visit or follow him on X (formerly Twitter) at @Quay_Dr. Public Relations Contact: Dunn Pellier Media| t: 323.481.2307 11620 Wilshire Blvd., 9th Floor, Los Angeles, CA 90025 [email protected] [email protected] SOURCE Dr. Steven Quay

Vaccine

100 Deals associated with Endoxifen

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mania	Phase 3	US	Jina Pharmaceuticals, Inc.	19 Mar 2024
Bipolar I disorder	Phase 3	US	Jina Pharmaceuticals, Inc.	03 Aug 2020
ER-positive/HER2-negative Breast Cancer	Phase 2	US	Inclin, Inc.	14 Feb 2023
ER-positive/HER2-negative Breast Cancer	Phase 2	US	Atossa Therapeutics, Inc.	14 Feb 2023
Estrogen receptor positive breast cancer	Phase 2	US	Inclin, Inc.	14 Feb 2023
Estrogen receptor positive breast cancer	Phase 2	US	Atossa Therapeutics, Inc.	14 Feb 2023
HER2-negative breast cancer	Phase 2	US	Inclin, Inc.	14 Feb 2023
HER2-negative breast cancer	Phase 2	US	Atossa Therapeutics, Inc.	14 Feb 2023
Invasive Mammary Carcinoma	Phase 2	US	Atossa Therapeutics, Inc.	14 Feb 2023
Invasive Mammary Carcinoma	Phase 2	US	Inclin, Inc.	14 Feb 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05068388 (KARISMA-Endoxifen, Company_Website) Manual	Phase 2	Breast Cancer	-	(Z)-endoxifen 1 mg	bdzfnlrljk(wvipezjehn) = qpucmzybhb hneduxqhnq (uqnqagfmnq ) View more	Positive	04 Nov 2024
NCT05068388 (KARISMA-Endoxifen, Company_Website) Manual	Phase 2	Breast Cancer	-	(Z)-endoxifen 2 mg	bdzfnlrljk(wvipezjehn) = yelwwidcpj hneduxqhnq (uqnqagfmnq ) View more	Positive	04 Nov 2024
NCT05607004 (EVANGELINE, AACR2024) Manual	Phase 2	Premenopausal breast cancer Neoadjuvant HER2 Negative \| Proliferation marker protein Ki-67 \| ER Positive	7	(Z)-endoxifen 40 mg/day	feozkbqfap(natrkzxzyn) = fvgwfxjgal agvyijubpr (pyxeycbehy, 180.3 - 376.6) View more	Positive	05 Apr 2024
NCT03317405 (CTgov)	Phase 1	Breast Ductal Carcinoma \| Breast Carcinoma in Situ \| Breast Cancer 3	32	Endoxifen Hydrochloride (Endoxifen Hydrochloride Gel 10 mg Daily)	fbhrnwosvq(rdujavsorb) = yyzrgazeua gaashvyrbv (dsvvufghre, ktdfqknwfe - sdibeawzpb) View more	-	13 Jun 2023
NCT03317405 (CTgov)	Phase 1		32	Endoxifen Hydrochloride (Endoxifen Hydrochloride Gel 20 mg Daily)	fbhrnwosvq(rdujavsorb) = ikkmpipkkh gaashvyrbv (dsvvufghre, exaywcinxh - xtyelqvgfx) View more	-	13 Jun 2023
NCT04616430 (CREME, CTgov)	Phase 2	Breast Diseases	90	Placebo (Control)	fzinjazepn(udlivqiqrg) = vswxkiqhhs ugwsrlugwb (ykrflyivkq, ayjecoqtbm - gwbyrwvztm) View more	-	18 Jun 2021
NCT04616430 (CREME, CTgov)	Phase 2	Breast Diseases	90	Topical endoxifen (Topical Endoxifen 10mg/Breast/Day)	fzinjazepn(udlivqiqrg) = znzadmvbig ugwsrlugwb (ykrflyivkq, tetqumzrxj - jbaamlfznf) View more	-	18 Jun 2021
NCT02311933 (AACR2020) Manual	Phase 2	HER2-negative breast cancer \| Estrogen receptor positive breast cancer HER2 negative \| ER Positive	77	Z-endoxifen HCL	dkdxipchog(wjdvabtvwz) = ifcpvnrqpl owkimdprmi (hsmablgebd, 76 - 138)	Non-superior	15 Feb 2020
NCT02311933 (AACR2020) Manual	Phase 2		77	tamoxifen	dkdxipchog(wjdvabtvwz) = psirjzpegw owkimdprmi (hsmablgebd, 24 - 129)	Non-superior	15 Feb 2020
NCT01273168 (ASCO2018) Manual	Phase 1	HR positive solid tumors HR Positive	40	Endoxifen	hslfbhljcb(jzeaxqryiw) = hypertension (13%), hyponatremia (8%), hypophosphatemia (8%), neutropenia (8%), dehydration (5%), and elevated ALT (5%) nqmbquqrgs (hwzelqglaj ) View more	Positive	04 Jun 2018
NCT01327781 (MC093C, ASCO2017)	Phase 1	Hormone refractory breast cancer	41	Z-endoxifen	reqjievgyo(ijbvlkmeaz) = xjskfkcjow kwgjaumucu (nnbowwauow, 13.4 - 43.1) View more	-	30 May 2017
AACR2014	Phase 1	Female Genital Neoplasms \| Estrogen receptor positive breast cancer \| Aggressive Fibromatosis	44	Endx	bytdwbtati(zxbteqnuqo) = mwhikfczeg qjtgcrqymk (bagerchasl ) View more	-	01 Oct 2014
ASCO2010	Not Applicable	Breast Cancer	40	Endoxifen	vbdauskyls(mdazrrnstq) = efgyjaslyw ilbaopbdla (xesxchigpn ) View more	-	20 May 2010

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Endoxifen

Overview

Basic Info

Structure

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation